Condition: Gestational Diabetes Mellitus (GDM) · Sponsor: Medical University of Vienna
The purpose of this clinical study is to investigate the potential effects of myo-inositol supplementation on changes in glycemic control parameters, oxidative stress, inflammatory biomarkers, psychometric markers, and body composition in participants with gestational diabetes mellitus (GDM). The study duration is 3 to 3.5 months, depending on the time of GDM diagnosis. Before the active phase begins, there is a 10-day observation period during which participants' blood glucose levels are monitored using a continuous glucose monitoring device. In the subsequent 12-14-week study phase, participants will receive a supplement based on random group assignment. They will be allocated either to an intervention group (myo-inositol + folic acid) or a control group (folic acid). Both supplements will be taken until delivery. The intervention group supplement contains 4 g myo-inositol and 400 μg folic acid (BIOGENA GmbH, Salzburg) and is to be taken twice daily with water - three capsules per meal. The control group supplement contains only 400 μg folic acid (BIOGENA GmbH, Salzburg) and is also taken twice daily, one capsule per meal. As this is a pilot study, both participants and study personnel will be aware of group assignments. Blood glucose measurements will be repeated mid-study (around the 33rd week of pregnancy) and at the end (37th week of pregnancy) using glucose sensors. To improve the evaluation of glucose measurements, participants will keep dietary logs during these p…
This description comes directly from the study's public registry record.
Michael Priv.Doz. Dr.med.univ. Leutner, PhD MSc · +43 1 404 00-60950 · michael.leutner@meduniwien.ac.at
Ricarda Rosalia Baron, MSc, Msc · +43 1 404 00-20690 · Ricarda.Baron@meduniwien.ac.at
Always discuss trial participation with your own doctor first.
| Allgemeines Krankenhaus (AKH) Vienna, Medical University of Vienna | Vienna, State of Vienna, Austria | Recruiting |
| Medical University of Vienna | Vienna, State of Vienna, Austria | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07685015